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The Metformin-FMD Trial

Information source: Radboud University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ischemia Reperfusion Injury; Endothelial Function

Intervention: Metformin (Drug); Pretreatment with metformin in combination of infusion of caffeine. (Drug); No pretreatment with metformin in combination with infusion of caffeine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Radboud University

Official(s) and/or principal investigator(s):
N. Riksen, MD, PhD, Principal Investigator, Affiliation: Radboud University
G.A. Rongen, M.D., Principal Investigator, Affiliation: Radboud University
D.H. Thijssen, PhD, Principal Investigator, Affiliation: Radboud University

Summary

In acute myocardial infarction early restoration of coronary blood flow is the most effective strategy to limit infarct-size. Paradoxically, reperfusion itself also aggravates myocardial injury and contributes to final infarct size, a process termed 'reperfusion injury'. Ischemia and reperfusion (IR)-induced endothelial dysfunction seems to play a pivotal role in this process, resulting in vasoconstriction and reduced blood flow to the already ischemic tissue. Recently, it has been shown that the glucose-lowering drug metformin is able to limit IR-injury in murine models of myocardial infarction, probably by increased formation of the endogenous nucleoside adenosine. In the current research proposal, the investigators aim to translate this finding to the human in vivo situation, using flow-mediated dilation (FMD) of the brachial artery as a well-validated model of (endothelial) IR-injury.

Clinical Details

Official title: Can Metformin Prevent Endothelial Ischemia and Reperfusion Injury? The Metformin-FMD Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Metformin-FMD trial: The effect of pretreatment with metformin on FMD of the brachial artery after forearm ischemia and reperfusion.

Control trial: the effect of caffeine on the protective effect of metformin on FMD after ischemia and reperfusion.

Eligibility

Minimum age: 30 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 30-50 years

- Written informed consent

Exclusion Criteria:

- Smoking

- Hypertension (in supine position: systolic BP > 140 mmHg, diastolic BP > 90 mmHg)

- Hyperlipidaemia (fasting total cholesterol > 5. 5 mmol/L or random > 6. 5 mmol/L)

- Diabetes Mellitus (fasting glucose > 7. 0 mmol/L or random glucose > 11. 0 mmol/L)

- History of any cardiovascular disease

- Concomitant use of medication

- Renal dysfunction (MDRD < 60 ml/min)

- Professional athletes

Locations and Contacts

Radboud University Nijmegen Medical Centre, Nijmegen, Gelderland 6500 HB, Netherlands
Additional Information

Starting date: May 2012
Last updated: May 17, 2013

Page last updated: August 23, 2015

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